esophageal squamous cell carcinoma
Conditions
Interventions
experimental group:paclitaxel polymer micelles and cisplatin combined with Camrelizumab
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years old, =75 years old, gender unlimited 2. Pathological diagnosis of thoracic esophageal squamous cell carcinoma 3. No distant metastasis was detected by imaging examination, and after discussion by the Department of Oncology, esophageal surgery, and imaging department, they were locally advanced patients with clinical stage cT2-4aN+ or cT3-4aN0, M0, ?, ?, ?A (AJCC 8th edition cTNM stage) who were resectable or potentially resectable and had clinical stage CT2-4AN + or CT3-4AN0, M0. 4 ECOG PS score: 0 to 1 5. Expected survival =6 months 6. No previous treatment with chemoradiotherapy, immunotherapy or other anti-tumor drugs 7. Adequate baseline organ function: the following blood routine parameters should be met: ? neutrophil count =1.5×10^9/L; 2. Hemoglobin =90g/L; ?. Platelet count =100×10^9/L The following blood biochemical parameters should be met: ? ALT and AST = 2.5×ULN; ?. Total bilirubin = 2×ULN; Plasma Cr = 1.5×ULN, or cCr=60ml/min 8. Cardiac function: no heart disease or coronary heart disease, patients with cardiac function 1-2; 9. For hypertensive patients, blood pressure should be controlled within the normal range by antihypertensive drugs; for diabetic patients, fasting blood glucose should be controlled to =8mmol/L by hypoglycemic drugs; 10. No other serious diseases that conflict with this protocol (such as autoimmune diseases, immune deficiencies, organ transplants, or other diseases requiring continuous hormone therapy); 11. No history of other malignant tumors; 12. The patient agrees to participate in the clinical study and signs the informed consent Form.
Exclusion criteria
Exclusion criteria: 1. Patients have previously received anti-tumor therapy (including chemotherapy, radiotherapy, surgery or immunotherapy) 2. Complicated with other malignant tumors (other than malignant skin tumors, cervical cancer in situ, and cured prostate cancer) 3. The patient has or is expected to have significant risk of esophageal perforation, fistula and major bleeding 4. Active autoimmune or immune deficiency diseases, immunosuppressants were used before enrollment, and the dosage of immunosuppressants was =10mg/ day oral prednisone for more than 2 weeks; 5. Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction, unstable or severe angina pectoris, coronary artery bypass surgery, congestive heart failure, ventricular arrhythmias requiring medical intervention, left ventricular ejection fraction 16s, APTT > 53s, TT > 21s, Fib < 1.5g/L), bleeding tendency or receiving thrombolytic or anticoagulant therapy; 11. Previous or current severe pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, severe impairment of lung function, etc., or had active tuberculosis within 1 year; 12. The presence of uncontrolled active hepatitis B or C; 13.Other limits that did not meet the inclusion criteria evaluated by the researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete pathologic response ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;major pathologic response;R0 removal rate;2-year survival rate;Disease-free survival; | — |
Countries
China
Contacts
Public ContactWei Ren & Zhendong Hu
Nanjing Drum Tower Hospital , The Affiliated Hospital of Nanjing University Medical School
Outcome results
None listed